Recently Posted Guidance Documents on Drugs and Biologics, Biosimilarity, ICH-Quality

Drugs

  9/22/2017 Expedited Programs for Serious Conditions––Drugs and Biologics

Biosimilarity

  9/21/2017 Statistical Approaches to Evaluate Analytical Similarity

ICH-Quality

  9/18/2017 Q4B Annex 5: Disintegration Test General Chapter

  9/18/2017 Q4B Annex 3: Test for Particulate Contamination: Subvisible Particles General Chapter

  9/18/2017 Q4B Annex 4C: Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter

  9/18/2017 Q4B Annex 8: Sterility Test General Chapter

  9/18/2017 Q4B Annex 2: Test for Extractable Volume of Parenteral Preparations General Chapter

  9/18/2017  Q4B Annex 10: Polyacrylamide Gel Electrophoresis General Chapter

  9/18/2017 Q4B Annex 4B: Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter

  9/18/2017 Q4B Annex 9: Tablet Friability General Chapter

  9/18/2017  Q4B Annex I: Residue on Ignition/Sulphated Ash General Chapter

  9/18/2017 Q4B Annex 4A: Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter

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